Subjects will be entered into one of 4 increasing dosages of 25% human albumin sequentially. Once the first 20 subjects have been enrolled and the DSMB reviews data and approves moving to the next dosage tier patients will be entered into the following dosage tier.

Subarachnoid Hemorrhage

25% human albumin given in four escalating doses:
Group 1: .625g/kg infused over 3hrs daily X 7day
Group 2: 1.25g/kg infused over 3hrs daily X 7day
Group 3: 1.875g/kg infused over 3hrs daily X 7day
Group 4: 2.5g/kg infused over 3hrs daily X 7day

Human Albumin

Baylor College of Medicine

Treatment of Subarachnoid Hemorrhage With Human Albumin

The study will investigate the number of patients experiencing moderate-to-severe acute heart failure for any given dosage tier directly related to treatment administration. Specifically, if at least 2 patients per dosage tier experience such serious event the study will be terminated.

The study will measure the the Glasgow Outcome Scale to obtain preliminary estimates of treatment effects.

The study will measure the the modified Rankin Scale to obtain preliminary estimates of treatment effects.

The study will measure the NIH Stroke Scale to obtain preliminary estimates of treatment effects.

The study will measure the Stroke Impact Scale to obtain preliminary estimates of treatment effects.

Jose I. Suarez

Professor of Neurology

Hypertension

Blood pressure lowering therapy except ARB

Non-ARB (standard therapy)

ARB (Telmisartan)

Department of Cardiovascular Clinical and Translational Research, Kumamoto University Hospital

A Trial of Telmisartan Prevention of Cardiovascular Disease

Hirofumi Soejima

Associate Professor, MD, PhD

Kumamoto University

Japan Foundation for Aging and Health

Dosage Tier 1

Dosage Tier 2

Dosage Tier 3

Dosage Tier 4

Total

Gender

Region of Enrollment

Tolerability outcome: Subject's ability to receive the full allocated human albumin dose without incurring frank congestive heart failure or experiencing anaphylactic reactions that required discontinuation of the treatment. Study would be terminated if 2 or more subjects developed severe or life-threatening heart failure considered to be related (probably, possibly, and definitely) to albumin treatment.

Safety and Tolerability of the 25% Human Albumin Dosages and the Functional Outcome.

Serious adverse events included neurological and medical complications and neurological deterioration.
Neurological deterioration was defined as a decline by more than 2 points in the Glasgow Coma Scale.

Serious Adverse Events

Number of subjects with good clinical outcome defined as a Glasgw Outcome Scale score of 0-1

Good Clinical Outcome Was Defined as a Glasgow Outcome Scale Score of 0-1

Overall Study

Jose I Suarez, MD, Professor of Neurology

25% human albumin: after approval by the Data and Safety Monitoring Board dosage tier would be escalated to the subsequent higher level sequentially.

subarachnoid hemorrhage/albumina

Treatment of Subarachnoid Hemorrhage With Human Albumin

A Trial of Telmisartan Prevention of Cardiovascular Disease

Treatment of Subarachnoid Hemorrhage With Human Albumin

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